BridgeMD
New treatment option for Obstructive Sleep Apnea
Official title Rescue Pharmacotherapy for OSA
ClinicalTrials.gov ID: NCT05293600
What this study is testing
What is Acetazolamide?
Acetazolamide is an investigational medicine, being studied as a potential treatment for obstructive sleep apnea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Persistent obstructive sleep apnea (OSA) is common in people treated with mandibular advancement device (MAD) or hypoglossal nerve stimulation (HGNS). For most patients, these treatments are the last line of defense.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70
You may be able to join if
- Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy.
You likely can't join if
- Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea: central sleep apnea (\>50% of respiratory events scored as...
- Other sleep disorders: periodic limb movements (periodic limb movement index \> 20/hr), narcolepsy, or parasomnias.
- Any unstable major medical condition.
- Medications expected to stimulate or depress respiration (including opioids, barbiturates, benzodiazepines, doxapram, almitrine, theophylline...
- Use of SSRIs/SNRIs.
- Contraindications for atomoxetine, including:
See the full eligibility criteria
- Individuals who have failed MAD or HGNS therapy, defined as a residual AHI ≥ 15 events/hr on MAD or HGNS therapy.
- Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea: central sleep apnea (\>50% of respiratory events scored as central), chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by...
- Other sleep disorders: periodic limb movements (periodic limb movement index \> 20/hr), narcolepsy, or parasomnias.
- Any unstable major medical condition.
- Medications expected to stimulate or depress respiration (including opioids, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
- Use of SSRIs/SNRIs.
- Contraindications for atomoxetine, including:
- pheochromocytoma
- use of monoamine oxidase inhibitors
- benign prostatic hypertrophy, urinary retention
- untreated narrow angle glaucoma
- bipolar disorder, mania, psychosis
- clinically significant constipation, gastric retention
- pre-existing seizure disorders
- clinically-significant kidney disorders
- clinically-significant liver disorders
- clinically-significant cardiovascular conditions
- severe hypertension (SBP\>180 mmHg or DBP\>110 mmHg measured at baseline)
- cardiomyopathy (LVEF\<50%) or heart failure
- advanced atherosclerosi
- history of cerebrovascular events
- history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation
- other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate
- myasthenia gravis
- pregnancy/breast-feeding
- Contraindications for eszopiclone, including:
- Hypersensitivity to eszopiclone
- Chronic Obstructive Pulmonary Disease (COPD)
- Pregnancy
- Breast feeding
- Liver disease
- Contraindications for acetazolamide, including:
- Hyperchloremic acidosis
- Hypokalemia
- Hyponatremia
- Adrenal insufficiency
- Impaired kidney function
- Hypersensitivity to acetazolamide or other sulfonamides.
- Marked liver disease or impairment of liver function, including cirrhosis.
- Contraindications for trazodone, including:
- suicidal ideation
- bipolar disorder, mania
- use of monoamine oxidase inhibitors
- coronary artery disease
- cardiac arrhythmias
- QT prolongation
- hepatic disease
- renal failure or impairment
- closed angle glaucoma
- priapism
- pregnancy/breast-feeding
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.